Prophylactic Pulmonary Vein Isolation Study

Atrial Fibrillation Clinical Trial

Official title:

A Randomized, Single-blind Prophylactic Pulmonary Vein Isolation Procedure Utilizing Bipolar Radiofrequency Ablation in Patients Undergoing Mitral Valve Surgery

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00587899
• Other study ID #: 06-005543
• Status: Terminated
• Phase: N/A
• First received: December 22, 2007
• Last updated: April 12, 2011
• Start date: January 2007
• Est. completion date: November 2009

Study information

• Verified date: April 2011
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This study is being done to learn the effects of the Pulmonary Vein Isolation in patients that are at high risk to developing, but do not have a documented history of atrial fibrillation.

Description:

Patients with a dilated left atrium (left upper chamber of the heart) that undergo mitral valve surgery may be at risk for the development of atrial fibrillation after surgery.

Atrial fibrillation (also known as "A-Fib" or AF) is an abnormal heart rhythm which may cause symptoms such as pounding sensations in your chest, dizziness, fatigue, chest pain and/or shortness of breath. AF patients are at a higher risk of developing a stroke.

Participants who sign informed consent will be randomized into one of two groups by chance (as in the flip of a coin).

Approximately 77 patients will undergo their mitral valve operation along with Pulmonary Vein Isolation (a treatment group) and 77 patients who do not undergo Pulmonary Vein Isolation at the time of their mitral valve surgery (a control group).

The treatment group will undergo operation for mitral valve disease with an additional procedure called Pulmonary Vein Isolation using a device that delivers radiofrequency energy to the heart muscle in order to create scar tissue to block electrical impulses that can trigger episodes of AF.

The control group of patients will undergo operation for mitral valve disease without the additional Pulmonary Vein Isolation.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 41
• Est. completion date: November 2009
• Est. primary completion date: November 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Indication for open-heart surgery: Mitral valve repair or replacement, evidence of a dilated left atrium

Exclusion Criteria:

• History of Atrial Fibrillation

• Need for emergent cardiac surgery

• Previous cardiac surgery

• Preoperative need for an intraaortic balloon pump or intravenous inotropes

• Current diagnosis of active endocarditis

• Mental impairment/or experience other conditions which may not allow subject to understand nature

• Significance and scope of study

• Pregnancy

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Procedure:
• Pulmonary Vein Isolation
The treatment group will undergo operation for mitral valve disease with an additional procedure called Pulmonary Vein Isolation using a device that delivers radiofrequency energy to the heart muscle in order to create scar tissue to block electrical impulses that can trigger episodes of AF.

Locations

Country	Name	City	State
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluated by the number of patients free of taking antiarrhythmic medications and free of AF as determined by a 24-hour Holter recording.		12 months	No

External Links

•   Mayo Clinic Clinical Trials